A Study to Assess Efficacy and Safety of CGB-500, 1% Tofacitinib Versus an Active Comparator for Atopic Dermatitis

Part of paid clinical trials in Fremont, California.

Sponsor
CAGE Bio Inc.
Study ID
NCT06923228
Phase
PHASE2
Status
Completed

Conditions

  • Atopic Dermatitis (AD)

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The goal of this clinical trial is to learn if drug CGB-500 works to treat atopic dermatitis in subjects 12 years of age or older. It will also learn about the safety of CGB-500. The main questions it aims to answer are: Does CGB-500 decrease the severity of atopic dermatitis on the skin? What medical problems do participants have when taking drug CGB-500? Researchers will compare CGB-500 to a an approved product (1.5% ruxolitinib) to see if CGB-500 works to treat atopic dermatitis. Participants will: Apply CGB-500 and ruxolitinib to different locations on their body twice a day for four weeks. Visit the clinic six times for checkups and tests Keep a diary of their symptoms and when they apply the product

Key Dates

Start date
Apr 21, 2025
Status verified
Apr 2025
Primary completion
Jul 30, 2025
Completion
Sep 30, 2025

Study Design

Enrollment
3 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CGB 500 ointment with 1% tofacitinib
    topical ointment
  • Active Comparator: ruxolitinib cream QD
    topical cream

Primary Outcome Measure

evaluate effectiveness [ Time Frame: From enrollment to end of study at 4 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Center for Dermatology Clinical ResearchFremontCalifornia94538-

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